JPH07505796A - improved venous valve cutter - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] improved venous valve cutter Background of the invention The present invention is useful for patients who require arterial reconstruction due to chronic local anemia that compresses their extremities. In order to create a bypass where the artery should normally be, the leaflet venous valve is removed. related to things. More particularly, the present invention provides an improved and unique cutting surface. and a cleaning system. The cutting surface is a leaflet valve. Facilitates excision. In addition, the cleaning system can be used to introduce and withdraw the cutter. minimize friction on the venous endothelium when

The usual chronic local anemia that compresses the extremities is a femoral tibial obstruction disorder, typically Treatment is performed using the larger saphenous vein as a bypass conduit. Traditionally, this A vein had been removed from the patient. The leaflet valves in the veins direct blood in one direction. To solve this problem, the veins have been used by turning them inside out. back The distal end of the returned saphenous vein is grafted and connected to the femoral artery, and its proximal end is connected to the femoral artery to clear the occluded area. The graft is connected to the outflow artery.

There are many unique problems with everting the saphenous vein and using it as a bypass tube. . The saphenous vein is thick at its proximal end and anastomoses to a distal outflow blood vessel measuring 2 to 3 mm. however, the distal end is narrow and does not allow sufficient arterial flow from the newly joined parent vessel. Do not allow inflow. In addition, once the saphenous vein is removed, it must be turned over and repositioned during the process. , the body is twisted or compressed and damaged. Also, if you take it out, you can rearrange it. During the process, it is extremely difficult to maintain the condition of the highly sensitive venous endothelium. Ru.

Furthermore, the process impairs the blood supply to the blood vessels (vasa vasa).

Removes existing veins in the body, without having to remove them, turn them over, and reposition them. If bypass is performed using the If you perform “in-situ vein bypass”, you can remove the vein and turn it inside out. and can solve most relocation problems. This thing is Usually, in the treatment of femorotibial occlusion disorders, a valve cutter is moved within the saphenous vein. This is achieved by removing the leaflet valve.

The technique disclosed by Carrel and Guthrie requires the anastomosis of small vessels; Surgeons attempted to revascularize the lower end of the groin. Use saphenous vein as is The advantages of this technique are, firstly, that the graft can be oriented and tapered in the appropriate direction. This allows the thin end to be anastomosed to the distal end of a small artery. This allows both anastomoses to blood circulation is improved. The second advantage is that the outer skin is removed to protect the endothelial layer of the vein. This means that the blood supply to the veins can be secured.

Generally, when performing an in situ venous bypass, the distal end of the vein is Anastomoses the femoral artery to direct arterial flow into the vein, or introduce saline into the vein through a cannula. circulates to provide the pressure necessary to dilate blood vessels and close valves. There is. This is done by using the valve cutter and the leaflet valve in the occluded state. This is to ensure that the leaflets are cut by contact. All lobes are Once removed, the vein is suitable for use as an arterial bypass conduit. Become.

Unfortunately, currently used valve cutters damage the venous endothelium. This allows the valve to be activated while preventing the cutter from coming into contact with the inner vein wall. It is very difficult to excise it uniformly. Valve cutter devices currently in use Many of them are difficult to operate. Align the device and properly capture and resect the leaflet valve. It is difficult to remove and causes considerable damage to the veins. It's a cutter The head comes into contact with the intima of the vein wall, and at that point, it connects to the blood vessel wall. This is because the leaflet valves that are present are removed.

U.S. Patent No. 3,837,345 (title: Venous Valve Snipper) Discloses a device for grafting a removed vein to bypass an occluded artery. this The device is not intended to be used in situ. The device has a closed position and an open position. position, move in the direction of blood flow through the venous valve, open, and withdraw It will be destroyed.

The sharp spike pierces the vein leaflet valve and the device is closed like operating scissors This causes the leaflet valve to be removed.

U.S. Pat. No. 4,493,321 (titled In Situ Resection of Bilobed Valve A venous valve cutter) is used in situ to perform an arterial bypass. Discloses an inverted arrowhead shaped valve cutter for preparing veins for use. this The valve cutter has a round leader and a cutting blade placed within a protective support. It has rigidity against torsion and connects the leader and cutting blade. attached with suture material to the connecting rod and the protective support of the cutting blade. It is equipped with a catheter. This valve cutter can be used at both the proximal and distal ends of the vein. An incision is made and fluid is introduced through the catheter to close the pre-ablation valve and administer static injections. Attach the valve cutter to the vein, pull down, and form the valve cutter assembly at the proximal end. It is used by placing it back into the incision. This device continuously controls its direction. The cutting blade captures and excises the narrow wall of a useful vein branch. to ensure that both lobes of each stroke are removed. It is necessary to

U.S. Patent No. 5,047,041 (title: In situ resection of venous valves) a) A circular cutter head attached to the cable, Discloses a valve cutter led by an expansion segment also attached to the cable are doing. The circular cutting edge has a series of rounded guide teeth . Guide teeth guide the leaflet into a cutting groove that engages and ablate the leaflet. unfortunately , this guide tooth is rounded and not sharp, so before the leaflet cutting begins, The leaflet is pulled, stretched, and torn.

Summary of the invention Accordingly, the present invention provides an improved static valve for use in in situ resection of leaflet valves. Regarding pulse valve cutters. The venous valve cutter of the present invention reduces frictional force in the vascular endothelium. Minimize and prevent accidental contact between the cutting surface and the lining of the vein wall. Together, they safely, effectively, and uniformly resect the leaflet valve.

An important object of the invention is a cutter used for in situ resection of leaflet valves. Do not pull, stretch, or tear the connection between the leaflet valve and the inner wall of the blood vessel. An object of the present invention is to provide a venous valve cutter.

Another important object of the invention is to provide a cutting blade for in situ arterial bypass. The procedure is to remove the venous valve using a venous valve. The cutter head of the cutting blade leaves When it comes into contact with the valve, it pierces almost at the same time.

Another object of the invention is to provide a venous valve cutter with an exchangeable cutter head. It is to be. With such a venous valve cutter, the surgeon can A head sized to fit the lumen can be selected.

Another object of the invention is to provide an integrated venous valve resection-irrigation system. . This system cleans and opens the valve and moves upward into the blood vessel prior to valve resection. Inflates the lumen of the blood vessel to prevent the device from coming into contact with the blood vessel when passing the device to facilitate alignment of the device.

Another object of the invention is to provide a valve cutter with a cleaning system.

In this cleaning system, fluid can flow back into the cutter head. , the cutting surface of the cutter head can be cleaned and lubricated.

Another object of the invention is to provide a venous valve cutter having a cutter head with a cylindrical portion. The goal is to provide the following: This cylindrical portion facilitates centering of the device within the vein. Make it.

Another object of the invention is to provide a venous valve cutter having a cutter head with a cylindrical portion. The goal is to provide the following: This vein valve cutter has a A flow path is also formed to facilitate the passage of fluid.

The improved venous valve cutter of the present invention has, as an important feature, multiple protrusions. It is equipped with a cutter head. Each protrusion is oriented generally proximally and slotted separated by. The protrusion has a flat cutting edge at the front end and , the protrusion has a cutting edge along its entire length. As a result, the protrusion first pierce the leaflet valve, and as the cutter cuts into the valve, the slot The cutting surface of the cutter continues to cut the valve. Furthermore, the present invention can be used for valve cutters. Concerning a unique cleaning system. In this cleaning system, the cutter As it travels through the blood vessel, saline or other fluid passes through the cutter head. child First, this minimizes trauma when the cutter passes through the blood vessels and valves. and increases the effectiveness of the shearing action when the leaflet is excised.

Brief description of the drawing The features of the invention believed to be novel are set forth in the appended claims. Ru. The invention, as well as its objects and advantages, will be further described below with reference to the accompanying drawings. It can be best understood by referring to the article.

FIG. 1 is a top view of the improved venous valve cutter of the present invention placed in a horizontal orientation. .

Figure 2 is an enlargement of the cutter head and leader of the venous valve cutter shown in Figure 1. It is a diagram.

FIG. 3 is an enlarged elevational view of the cutter head shown in FIG. It is a figure seen from the protrusion part side.

FIG. 3A is an enlarged elevational view of a modification of the cutter head shown in FIG. - is a view of the head viewed from the protrusion side. A flow path is formed to allow passage through narrow blood vessels. Smooth fluid flow even when passing.

FIG. 4 is an enlarged view of the cutter head shown in FIG. 1 in a position along line 4-4 in FIG. FIG.

FIG. 4A is a schematic diagram illustrating a replaceable valve cutter head.

FIG. 4B is an elevational view showing a rounded head. replaceable cutter head When used, this head facilitates the installation of the venous valve cutter.

FIGS. 40 and 4D show another example of a replaceable valve cutter head leader. 4E is an elevational view of another embodiment of the catheter.

The catheter of FIG. 4E is similar to that shown in FIG. 9, described below, as well as that shown in FIGS. 4C and 4D. It also fits into an integrated object.

FIG. 5 is an enlarged view of the cutter and reader assembly of the device shown in FIG. This is shown in a cross-sectional view taken along line 5-5 in FIG.

FIG. 5A is an enlarged view of the cutter and reader assembly of the device shown in FIG. 2, and is shown in a cross-sectional view taken along line 5-5 in FIG. cutter head and An optional cleaning port is formed in the system.

6A to 61 are explanatory views showing the operation of the valve cutter shown in FIG. 1.

FIG. 7 shows a planar view of the continuously formed cutting surface according to the present invention. FIG.

FIG. 8 is an enlarged sectional view showing a cutter head according to the present invention. The leaflet valve is removed A mechanism is provided to backwash the cutter head in the event of a spill.

FIG. 9 is an enlarged view of another embodiment of the improved venous valve cutter of the present invention.

Observe the action of the cutter head to resect the blood vessels and valves and evaluate the effectiveness of the resection. Optical fiber elements are employed to

Description of the preferred embodiment The improved venous valve cutter or valve dissector of the present invention is generally shown in FIG. 1 with the reference numeral 10. is shown. In the following, the in-situ bypass will be taken as an example. However, it is not limited to such uses; It can be applied to any surgery that requires a non-invasive transplant. example For example, infrainguinal distal bypass when non-dissection is required (e.g. Bypass from the thigh to the anterior tibial artery deep in the body) or in the lower inguinal area It can also be applied to bypasses using synthetic veins and bypasses between the aorta and kidneys. can be done.

The valve cutter 10 includes a cutter head 12, a leader 14, and a cutter head. The stem 15, catheter 16, handle 18, and It is equipped with a Bino\Booinshiekuntan port assembly 20.

The cutter head 12 is safe for internal use and retains a knife blade. It can be made of any metal that can be made. Material for cutter head Stainless steel is preferred. The valve cutter of the present invention is, for example, 1.5 mm. , 2.4mm, 3.0mm, 4.0mm or other size diameter cutters. It can be equipped with a head. The size of the cutter head is smaller than the size of the vein. Although it is preferable that the size be smaller, the selection is arbitrary.

FIG. 2 is an enlarged view of cutter 12 connected to leader 14 by stem 15. Ru.

The distal end of the cutter 12 has a frusto-conical shape 22, and the distal end 24 has a shape. The opening provided provides a wash port 26. The cleaning port 26 is located inside the center. It communicates with the cavity 27 (see FIGS. 4 and 5). The end 28 of the wash port 26 is , preferably rounded to minimize damage to the lining of the blood vessel. stomach.

A first cylindrical portion 30 is located immediately in front of the conical portion 22 . Cone The surface of the shaped portion 22 is smoothly continuous with the surface of the first cylindrical portion 30. 1st yen The circumferential surface of the cylindrical portion 30 is cut away from the position indicated by 32, and the first circle A second cylindrical portion 34 having an outer diameter slightly smaller than the outer diameter of the cylindrical portion 30 is formed. has been done. By forming the second cylindrical portion 34 with a small outer diameter, the cover is further reduces the risk of damage to the inner wall of the blood vessel when the tube passes through the valve. It will be done.

A plurality of protrusions 36 extending in the proximal direction are provided at the proximal end of the second cylindrical portion 34. It is. The protrusion 36 is a part that plays an important role. Preferred fruit illustrated In the example, four protrusions 36A, 36B, 36C, and 36D are shown. However, at least two protrusions are required. In addition, a larger number of protrusions may be provided. You can also Each protrusion has a semi-elliptical slot formed in the second cylindrical portion 34. 38.

The inner ends of the protrusions 368 to 36D defined by the slots 38 are shown in FIG. As best shown, it tapers to edge 40. And sharp , provides a sharp cutting surface 41. Furthermore, the flat front end 42 of the protrusion is sharp at the point 44 on its inner surface, and has a similarly sharp cutting edge. They offer azaleas. In this way, the cutter head 12 has its front edge 4 Cutting surfaces are continuously formed on a plurality of surfaces along the entire circumference of 6. cutter The forward edge 46 of the helad 12 is shown in FIG. In Figure 7, the cutter head The wall of the door 12 is shown in a flat, expanded state. With such a configuration , the flat anterior end 42 of the protrusion pierces the leaflet. And eight sharp cuts The cutting surface 41 extends the cutting width until the cutter is pulled and the apex 43 of the slot is reached. Continue cutting the venous valve by gradually widening it. And the whole valve is clean from its center and collected at the position indicated by 45 in the cutter head (see Figure 5). .

Although it is preferred to use a reader 14, it is not essential to the invention. .

The leader 14 is attached to the cutter head 12 via a rigid stem 15. ing.

The axis of stem 15 is coincident with the axes of both the cutter and the leader. Also, As shown in FIG. 5, stem 15 is hollow and is removable from wash port 26. It forms a lumen extending to the distal end 50 of the reader. Spring with rigidity 15, and separate cleaning due to the gap between the coils that make up the spring. A location may be provided. Finally, the stem 15 has leaflets (passing through the leader). (after the protrusions 36^ to 36D) are allowed to close before coming into contact with the front ends 42 of the protrusions 36^ to 36D. It must be long enough to

Leader 14 has a conical surface 70. Conical surface 70 is a cylindrical surface 72 and further to the rear conical surface 76. Ru. A nipple 78 is provided at the proximal end of the leader where catheter 16 is inserted. can be installed.

In another embodiment, a tightly wound coil spring is covered with a non-stretchable sheath. The catheter 16 is constructed by the bar. The coil spring is stainless steel The sheath is preferably made of steel with low surface friction, such as polyurethane. , those that are less likely to cause thrombus are preferred. Structure that covers such a coil with a sheath has rigidity in the longitudinal direction, as well as conformability, deformability, and flexibility. Easy to align.

Catheter 16 is a plastic shell made of polyurethane or other suitable material. is attached to the handle 18. The doctor uses this handle when passing the device into the vein. and rotate the cover head if necessary. However, physically rotating the device Even if not rotated, advancing the cutting edge of the protrusion will cause the leaf-like A notch is formed in the valve so as to surround it from the periphery.

The hub-injection port combination 20 is connected to a saline source (not shown). ing. Prior to valve cutting, a valve cutter is introduced into the blood vessel to clean and open the valve. When the saline or other fluid flows out of the irrigation port, it dilates the blood vessel and displaces the implant. Helps align the placement. This minimizes trauma to the vessel wall and reduces trauma. Therefore, it is possible to maintain a blood vessel wall that does not easily cause blood coagulation. figure In another embodiment shown at 58, the conical section 22 or stem 15 is A port 21 is formed. This increases the cleaning effect of the cleaning port 26. or if the wash port 26 can be plugged with a cap. It is designed as a replacement.

The valve canter of the present invention does not allow proximal anastomosis to be performed prior to valve resection. It has particular advantages over other devices in some cases. In the present invention, it is a valve cutter. When performing cutting of the leaflet valve by This is because the cutting blade comes into contact with the cutting blade.

Furthermore, in the valve cutter of the present invention, the bundle of small optical fibers is − can be inserted into the cleaning channel in the can be understood. In other embodiments, the optical A fiber bundle 150 is placed within the leader 14 of the valve cutter and cuts the valve. The movement of the cutting surface can be monitored by the surgeon.

In yet another embodiment, as shown in FIG. The lower part is cleaned at . In this example, saline or other The body is passed from the catheter 100 to the back 102 of the cutter head. The saline solution It accumulates in the rear part 102 and is discharged from the port 104. Then cut into the leaflet valve. Clean and lubricate the cutting edge of the ivy head.

6A-61, valve cutter 10 is removed from proximal end 110 of vein 112. It has been introduced. Then, before the cutter head advances, the heparinized saline solution is 14 exits from a wash port 26 in the cutter head of the valve cutter and drains the vein 1. 12 is expanded and lubricated. [’N6B and as shown in Figure 60, the force - To the ivy - Rad beyond the valve 116 consisting of the leaflet valves 116^ and 116B Advance. The pressure gradient in the flush port 26 causes the valve cutter to be lobed before it advances. The valve is opened (see Figure 6B). Then, as shown in FIG. 60, the valve cutter is Pass through the valve. Make sure the valve is sufficiently lubricated with saline before moving forward. Ru.

After the cutter head of the valve cutter passes the valve, the valve force and the direction of travel of the valve are reversed. (See FIGS. 6D to 614). At this time, the valve force is at the most proximal side of the vein. It will be located in Then, hydrostatic pressure is applied gently again to the nearest position. Existing valves are closed. By reducing the pressure gradient of the drain water, the valve cutter inflates to prevent damage due to hydrostatic pressure when slowly moving forward in a floating state, and should be minimized. Front end 42 of the cutter head projection A small incision may be formed when the leaflet valve contacts the closed leaflet valve close to the vein wall. Hydrostatic pressure is maintained so that This small notch is a curved force The valve is gradually expanded by the gripping surface 41 (see FIGS. 6F-6H) and the valve is resected.

And Figure 511. m As shown, the location where the valve was originally located is Almost no damage remains. Cleaning during the above process is done statically using hydrostatic pressure. Sufficient to center the device while minimizing the risk of damage to the pulse. It is carried out to a certain degree.

At this time, the valve cutter 10 is placed near the distalmost valve to be cut next. position, and hydrostatic pressure is again gently applied to close the next valve.

Then, this valve is removed as described above (gradually removed. The valve is removed while the hydrostatic pressure is maintained). Cutter attack is lowered by 1. Subsequently, the next valve is removed, and all The valve is removed.

If the surgeon created a proximal anastomosis before using the valve cutter (like , systemic arterial pressure closes the valve and plugs the irrigation port to prevent blood loss. do. However, the formation of a proximal anastomosis may occur during the initial period when the valve introduces a canker. This does not reduce the advantage of lavage at the distal end of the vein. ). In addition, surgeons can reduce valve force by passing a bundle of optical fibers through the irrigation channel. Sotarka (You can observe how the valve is cut while moving downward.

In another embodiment shown in FIG. 3A, the cylindrical portion 30 of the force Flow paths 110^ to 110D are formed in the tube, and the narrowing of the blood vessel LX Fluid may pass through channels 110A-110D as it passes through the section. child This prevents unnecessary compression and allows the cutter to pass through narrow areas. You can also ensure lubrication when doing so.

In still other embodiments of the invention, a single valve force/torque assembly; A series of cutters of different sizes are provided as tools. child An implementation of flI is shown in FIG. 4A. Inside of replaceable cutter head 120 A female threaded portion 122 is formed in the valve cutter assembly. sized to engage a corresponding male threaded portion 124 formed on the distal end of the body stem 126; It is considered a law. In this way, the cutter head 120 is Can be replaced with a different size cutter head. With a rounded head If replaced, initial placement of the device is facilitated. Round tip shown in Figure 4B The head 130 includes a body 132 having a rounded portion 134 and a cleaning boat 134; and an internal threaded portion 135.

Another interchangeable cutterhead-leader assembly 136 is shown in Figure 4c. .

The integral part 136 includes a leader 138, and an internal thread is provided inside the leader 138. A portion 138 is formed. This female threaded portion 138 is connected to the catheter 142 (FIG. 4D). The dimensions are such that it can engage with the corresponding male threaded portion 140 formed at the end of the Ru.

In using the replaceable cutter head shown in Figures 4A-40, first Pass the valve cutter assembly with the rounded head 130 through the vein from the most proximal end. vinegar. During this process, heparinized saline is added to the boat prior to advancing the device distally. It is drained from the veins and the veins are distended. Use a clamp or an assistant's finger to The distal end of the pulse closes gently and the vein expands. When the vein swells, the valve dissector Slowly move forward toward the distal end in a floating state.

When the catheter reaches the opening at the junction of the saphenous and femoral veins (or If a distal anastomosis was performed prior to valve resection, the catheter when passing the appropriate tributary on the side), the rounded head is removed and the appropriate size Replaced with a new valve cutter head. Clamp again at the saphenous cul-de-sac where the saphenous vein opens. is pressed. The surgeon selects the cutter head appropriate for the size of the patient's saphenous vein. There must be.

At this time, the valve cutter is located at the most distal side with respect to the valve. Pass the catheter through A fluid is ejected, which expands the lumen of the blood vessel and passes over the cutter head. return and close the valve. The valve is disconnected in this closed state. Fluid gushes out This is done to inflate the blood vessel and keep the device floating, and to close the valve and close the cap. This is to enable contact with the cutter head.

The valve cutter is pulled to engage and cut the distal valve. Valve slowly at constant speed It is necessary to pull the cutter. Hydrostatic pressure is maintained and the valve cutter assembly is pulled. It is lowered and engages the six valves in line to cut them out. Valve cutter is selected The cutter head is pulled until all valves within a suitable range have been removed. . If the catheter is inserted into the unclamped end of the junction of the saphenous and femoral veins, The surgeon determines that it has passed and the cutter head intersects with the larger head. will be replaced.

The above process is repeated to create a cutter head of the appropriate size for the lumen of the blood vessel. selected again. Blood vessels by selecting an appropriately sized valve cutter head The valve can best be cut off at a predetermined location within. cutter head Preferred sizes are ■, 5mm, 2.4m, 3.0mm, and 4. ha etc. Ru. The size of the cutter head chosen is at the discretion of the surgeon, but It is preferable to select a cutter head with a smaller size. this catheter The cutter head can be changed, allowing the surgeon to cut into the tapered vessel lumen. You can choose a suitable head.

Finally, conventional devices with optical fibers allow the surgeon to view the distal end of the valve. However, it is not possible to observe the cutting edge that penetrates the valve. it is This is because when the cutter penetrates the valve, the blood vessel contracts. As shown in Figure 9 With this device, it is possible to observe the root of the valve, and the blood vessels are shrunken. The cutting edge that penetrates the valve can be observed without cutting. In this way, The surgeon can see all six valves penetrated by the cutting edge.

That is, FIG. 9 shows an enlarged portion of another embodiment of the improved venous valve cutter of the present invention. A partial diagram is shown. In this embodiment, fiber optic elements are employed. This allows you to observe the action of the cutter head as it cuts out the blood vessels and valves. The effectiveness of removal can be evaluated. In this example, the cutter head A cut end 150 is secured to a leader 152. Inside the reader 152 is an optical A fiber element 154 is disposed. This unique optical fiber The configuration allows the surgeon to remove the cap while resecting the six valves using conventional equipment (not shown). The cutting edge of the cutter head can be observed.

Many variations to the preferred embodiments described herein will occur to those skilled in the art. It will be easy to make changes and modifications. Such changes and modifications shall not be considered as technical aspects of the present invention. This can be done without departing from the target range and without reducing its advantages.

Accordingly, such changes and modifications are also covered by the claims.

Continuation of front page (72) Inventor Goldbarb, Nidward M. Illinois, USA 225 (72) Mable Hill Road, Glenlo, 60022 Inventor: Linician, Lev Buffalo Grove, Cambridge, Illinois 60089, United States ・Drive 101 morning

Claims (1)

[Claims] 1. In a venous valve cutter that removes leaflet vein valves, this cutter removes leaflet valves. A circumferential shape that is oriented in the direction in which the cutter moves within the vein when cutting the vein. It has a cutter head with a cutting edge having a tip of The circumferential cutting edge has a plurality of sharp protrusions facing toward the proximal end. It is The protrusion is flat at its front end and similarly slotted into a slot providing a sharp edge. more separated from each other, The cutter head has multiple stages extending continuously along the entire circumference of its circumferential tip. Venous valve cutter with cutting surface. 2. The venous valve cutter of claim 1, wherein the slot is semi-elliptical in shape. 3. In a venous valve cutter that removes leaflet vein valves, this cutter removes leaflet valves. A circumferential shape that is oriented in the direction in which the cutter moves within the vein when cutting the vein. It has a cutter head with a cutting edge having a tip of The cutter head is configured to direct fluid distally into the cutter head. A venous valve cutter, to which a means is attached. 4. Improved venous valve cutter with circumferential cutting edge and advance the cutter head intravenously to resect the leaflet valve. and a means for advancing the circumferential cutting edge toward the proximal end. The front end has multiple sharp protrusions, The front end of the protrusion is flat and provides a sharp cutting edge as well. Venous valve cutters, separated from each other by slots. 5. 5. The venous valve cutter of claim 4, wherein the slot is semi-elliptical in shape. 6. 5. The venous valve cutter of claim 4, wherein said advancement means is a catheter. 7. 5. The venous valve of claim 4, wherein the cutter head is made of stainless steel. cutter. 8. 5. The venous valve of claim 4, wherein the distal end of the cutter head is frustoconically shaped. cutter. 9. a leader having a diameter approximately equal to the diameter of the cutter head; 5. The venous valve cover of claim 4, further comprising a stem connecting the head and the reader. ter. 10. 10. The venous valve cutter of claim 9, wherein the stem is highly rigid. 11. An opening is formed at the distal end of the cutter head, and the opening is located at the front end of the cutter head. 7. The venous valve cutter of claim 6, wherein the venous valve cutter communicates with the lumen of the catheter. 12. The surface of the cutter head smoothly continues into the cylindrical part, and The cylindrical part has its circumferential surface cut away to form a second cylindrical part with a slightly smaller diameter. The venous valve cutter according to claim 4, wherein a venous valve cutter is formed. 13. Four protrusions separated from each other by four slots and directed proximally The venous valve cutter according to claim 4, comprising: 14. The venous valve according to claim 4, wherein the inner end of the protrusion has an inclined surface. cutter. 15. 5. The front end portion of the protruding portion is flat and has an inclined surface. Venous valve cutter. 16. The stem is a highly rigid coil spring, and due to the gap between the coils, 10. The venous valve cutter of claim 9, wherein separate irrigation positions are provided. 17. The catheter has a tightly wound coil spring with a non-stretchable sheath. 7. The venous valve cutter of claim 6, further comprising a covering. 18. Claim: The sheath is made of a material that is highly smooth and does not easily generate blood clots. 17. The venous valve cutter according to 17. 19. A port is formed in the proximal region of the cutter head; The cutting edge of the cutter head is cleaned and lubricated via the The venous valve cutter according to claim 4. 20. A flow path is formed in the cylindrical part of the cutter head, and the cutter head 4. Fluid flows through this channel when the tube passes through a narrow portion of the blood vessel. Venous valve cutter as described. 21. A method for in situ removal of leaflets from a vein, comprising: a) sharp edges; and a plurality of proximal ends separated from each other by slots that also have tax edges. With the protrusion directed to the side, the cutter head is advanced intravenously to excise the leaflet valve. a valve cover having an advancement means for moving the cutter head and a cleaning channel formed at the distal end of the cutter head; b) advancing the cutter head within the vein; c) introducing fluid from the cleaning channel while The direction of movement of the cutter head of the valve cutter while maintaining the hydraulic pressure that can close the leaflet valve. reversing the cutter head and advancing the cutter head intravenously; d) Make a small incision by bringing the cutter head into contact with the leaflet valve near the vein wall. A groove is formed and the leaflet valve is excised by the cutting surface of the slot of the valve cutter. Gradually widen this incision and collect the removed leaflet valve in the cutter head. process, and e) a method comprising the step of excising the next leaflet. 22. A bundle of optical fibers is passed through the irrigation channel, and the valve cutter is inserted into the vein. You can observe how the leaflet valve is resected as the leaflet is advanced downward. The method according to claim 21. 23. A cutter head with a circumferential cutting edge at the tip and an intravenous A catheter that advances the cutter head to resect the leaflet valve, and a cutter head. Equipped with a leader with a diameter approximately equal to the diameter of , an improved venous valve cutter comprising: The circumferential cutting edge has a plurality of sharp protrusions facing toward the proximal end. It is The protrusions are connected to each other by slots that provide sharp cutting edges as well. It is separated by A gap between the coils forming the coil spring provides another cleaning position. venous valve cutter. 24. The catheter has a tightly wound coil spring with a non-stretchable sheath. 24. The venous valve cutter of claim 23, further comprising a covering. 25. Claim: The north is made of a material that is highly smooth and does not easily cause thrombus. 24. The venous valve cutter according to 24. 26. A method for in situ removal of leaflets from a vein, comprising: a) sharp edges; and a plurality of proximal ends separated from each other by slots also having competing edges. With the protrusion directed to the side, the cutter head is advanced intravenously to excise the leaflet valve. a valve cover having an advancement means for moving the cutter head and a cleaning channel formed at the distal end of the cutter head; b) advancing the cutter head within the vein; c) as the valve cutter advances downward; The bundle of optical fibers is washed with a cleaning stream so that the leaflet can be observed as it is removed. d) Applying hydraulic pressure that can close the leaf valve located on the front side of the cutter head. While maintaining the position, reverse the moving direction of the cutter head of the valve cutter and move it to the cutter. advancing the rod intravenously; e) Make a small incision by bringing the cutter head into contact with the leaflet valve near the vein wall. A groove is formed and the leaflet valve is excised by the cutting surface of the slot of the valve cutter. Gradually widen this incision until process, and f) a method comprising the step of excising the next leaflet. 27. Multiple interchangeable cutter heads of different sizes and the cutter head you need 5. A venous valve cup as claimed in claim 4, further comprising means for attaching a card to said advancement means. Ta28. A venous valve cutter assembly for cutting a leaflet valve, the assembly comprising: a cutter head, and an advancing means for advancing the cutter head, Equipped with multiple interchangeable cutter heads of different sizes, these cutters - the head can be removably attached to said advancement means, so that the leaflet valve In the process of cutting the blood vessel, a cup of a size that matches the size of the tapered blood vessel lumen is used. An assembly that can be replaced with a tar head. 29. a cutter with a rounded tip that can be removably attached to the advancing means; 29. The assembly of claim 28, comprising: - a head. 30. A kit for resecting a leaflet valve in a vein, the kit comprising: advancing a cutter head; an advancement means for moving the vehicle, and different services that can be removably attached to the advancement means. with multiple interchangeable cutter heads, resulting in cutting of the leaflet valves. In the cutting process, a cutter of a size that matches the size of the tapered blood vessel lumen is used. A kit that allows you to replace the head. 31. A method for in situ removal of a leaflet valve from a vein, the method comprising: a) having a rounded tip; Valve cutter equipped with a cutter head with a cutter head and a cleaning channel formed at the end. - introducing the assembly from the proximal end of the vein; b) said cutter having a rounded tip; – Inflate the vein by introducing fluid from the distal end of the head, keeping the vein inflated. , distally advancing the valve cutter assembly; c) The valve cutter assembly is located at the junction of the saphenous and femoral veins or in a suitable distal branch. When the flow is over, remove the cutter head with the rounded tip and remove the cutter head. Replace the cutter head with an appropriately sized cutter head that has a cleaning channel formed in the At the point of the saphenous hiatus where the vein opens or at the point distal to the valve of the distal saphenous vein. the process of clamping; d) Place the cutter head at the most distal side of the vein and pass through the lumen within the cutter head. ejects fluid to expand the vessel lumen, allowing the fluid to pass further over the cutter head. and closing the leaflet valve; e) Pull the valve cutter assembly back to engage and cut the furthest valve. and align the valve cutter assembly by pulling it down until all leaflets are excised. engaging and dissecting each valve while maintaining hydrostatic pressure; and f) tapered Multiple size cutters with cutter heads sized to match the size of the vessel lumen repeating steps d) and e) while selecting from the head; Method. 32. optical fiber means disposed proximate said circumferential cutting edge; It is equipped with It is possible to observe the action of the cutting edge as the valve cutter advances through the blood vessel. 5. The venous valve cutter of claim 4, wherein the venous valve cutter is capable of evaluating the effectiveness of ablation. 33. disposed in the leader near the circumferential cutting edge; equipped with optical fiber means, It is possible to observe the action of the cutting edge as the valve cutter advances through the blood vessel. 5. The venous valve cutter of claim 4, wherein the venous valve cutter is capable of evaluating the effectiveness of ablation.